MAUDE Adverse Event Report: ACCESS BIO INCORPORATE CARESTART COVID-19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem False Positive Result (1227)

Patient Problems Emotional Changes (1831); Distress (2329)

Event Date 03/26/2021

Event Type  malfunction  

Event Description

False positive covid-19; received false positive antigen test done at a work event which caused loss of income due to quarantine and sever emotional distress.I followed up the next day with a pcr test from an urgent care facility and another antigen test at a (b)(6) location and both tests were negative.I believe the testing media used in the carestart test was faulty or contaminated, or the test administrators performed the test improperly, mishandled the testing equipment, or made an error and contacted the wrong patient.This caused severe stress and loss of work/income for three days while i waited for new test results to come back.Fda safety report id# (b)(4).

• Brand Name: CARESTART COVID-19 ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACCESS BIO INCORPORATE
• MDR Report Key: 11601837
• MDR Text Key: 243597432
• Report Number: MW5100445
• Device Sequence Number: 1
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 52